Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT01210820
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2010-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility of iFS™ for Intrastromal Arcuate Keratotomy (ISAK) Procedures
Sponsor:
Abbott Medical Optics
Organization:
Study Overview
Official Title:
A Prospective Single Center Study To Evaluate the Feasibility of Intrastromal Arcuate Keratotomy Performed With the IntraLase iFS™ Femtosecond Laser System
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The results of this trial will demonstrate that ISAK performed with the iFS™ femtosecond laser is a safe procedure.
Detailed Description:
Surgeon will perform intrastromal arcuate keratotomy in arc segment patterns using the iFS™ femtosecond laser to treat subjects with refractive astigmatism.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: